Aurobindo's Unit IV under USFDA scanner

FDA Form 483 is issued to a firm at the conclusion of an inspection when investigators have observed any conditions, that in their judgement, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.TNN | Updated: May 10, 2017, 06:18 IST

The decision was based on the evaluation by United States Food and Drug Administration (USFDA) of its preclinical and clinical data of phase I establishing safety and clinical scope of efficacy for the drugHyderabad: In yet another setback for city-based pharma player Aurobindo Pharma, its Unit-IV at Pashamylaram on the city's outskirts has come under the scanner of the US drug regulator. The US Food and Drug Administration (USFDA) has issued a Form 483 to the company’s Unit-IV citing seven observations relating to violation of current good manufacturing practices (cGMP) following an inspection that was held during April 20-28 this year.

According to USFDA, FDA Form 483 is issued to a firm at the conclusion of an inspection when investigators have observed any conditions, that in their judgement, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The FDA Form 483 notifies the company’s management of objectionable conditions.

The USFDA inspectors observed that buildings used in the manufacturing of "drug products were not maintained in a good state of repair". It said that the changes to written procedure were not drafted, reviewed and approved by the appropriate organizational unit. USFDA also observed that equipment used in the manufacturing, processing, packing or holding of drug products was not of appropriate design to facilitate operations for its intended use. It added that procedures designed to prevent microbiological contamination of drug products purporting to the sterile were not established. The company’s unit-IV manufactures generic sterile injectables (lyophilized and powder injections, prefilled syringes), opthalmics and low volume parenterals. The facility is spread over 33 acres with a built-up area of 20,000 square meters.

Last month, the company’s unit III at Bachupally had come under the USFDA lens which had issued six observations. Aurobindo's Unit III is an exclusive multi-product oral dosage form facility, spread over 40,469 sq meters, for making non-cephalosporins and non beta-lactams.

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